Technical Writing Support for GxP Compliance - Overview
Guidelines, Standard Operating Procedures (SOPs), and document templates are the backbone of pharmaceutical and Regulatory industries. SOPs and document templates are not just a preference, it is a legal requirement.
Freyr has an in-house technical writing capability that enables consistent, organized, and straightforward document language, used to execute the successful completion of GxP and critical business-controlled tasks. We provide end-to-end Regulatory support with guidelines insights, drafting of the SOPs, and document templates which will fulfill the highest levels of quality, safety, and Regulatory compliance.
The content is developed as simply and as effectively as possible, ensuring easy language for readers in a way that they can understand and apply, even without prior knowledge of the subject matter.
Our Technical Writing services include:
- Draft the document following the sponsor-specific template (or Freyr template) and style guide
- Quality review and document proofreading
- Manage the workflow system for SOPs, guidance documents, work instructions, etc.
- Manage project timelines in coordination with the sponsor's requirements.
- Ensure periodic review changes and updates
Technical Writing Support for GxP Compliance
- A Team of experienced technical writers who are skilled in translating complex technical information into clear and concise documents
- In-depth knowledge of industrial standards and best practices for technical writing
- Qualified Subject matter experts provide insights and technical knowledge that enhance the quality and accuracy of the technical writing projects
- Support review and template alignment activities
- Support document authoring for updates and workflows
- Alignment with quality management system (QMS) workflow and administration
- Perform proofreading, periodic reviews, and co-authoring with authors/ SMEs as per requirements
- Execution of document development for major re-write or new document preparation
- Manage project timelines with Authors/SMEs
![Technical Writing Support for GxP Compliance](/sites/default/files/images/Technical-Writing-Support-for-GxP-Compliance-Expertise.webp)
- Team of Technical writers (TW) with diverse skills and expertise for comprehensive support
- Technical writers skilled in working with styles, formatting, and publishing within MS Suite
- Team of Qualified members to manage multiple projects and prioritize in stipulated timelines
- Freyr TW team focuses on driving consistency of documentation, efficiency of workflows, quality of content, and effectiveness of process
- Efficient in the communication of complex technical concepts and providing cost-effective solutions for technical writing needs
![Technical Writing Support for GxP Compliance](/sites/default/files/images/Technical-Writing-Support-for-GxP-Compliance-Advantages.webp)